SOMATOM DEFINITION

System, X-ray, Tomography, Computed

SIEMENS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Somatom Definition.

Pre-market Notification Details

• Device ID: K052216
• 510k Number: K052216
• Device Name: SOMATOM DEFINITION
• Classification: System, X-ray, Tomography, Computed
• Applicant: SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406
• Contact: Gary Johnson
• Correspondent: Gary Johnson; SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-08-03
• Decision Date: 2005-09-08
• Summary: summary